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Completed

NCT Number: NCT00973934

Magnetic Seizure Therapy (MST) for the Treatment of Major Depression

This two-center, between-subject, randomized, double-masked study (n=20) will provide the first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast the therapeutic properties and side effects of two forms of MST in patients in a major depressive episode (MDE).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke Universtiy Medical Center, Durham, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
  • Age 18-75
  • Use of effective method of birth control for women of child-bearing capacity
  • Willing and capable of providing informed consent
  • Convulsive therapy clinically indicated
  • Hamilton Rating Scale for Depression (HRSD) ≥18 (24 item)

Exclusion criteria

  • Current unstable or serious medical condition, or any comorbid medical condition that substantially increases the risks of ECT (such as acute myocardial infarction, space occupying brain lesion or other cause of increased intracranial pressure, unstable aneurysm or vascular malformation, poorly controlled diabetes mellitus, carcinoma, renal failure, hepatic failure)
  • Pregnancy
  • History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, or structural brain lesion
  • Presence of devices that may be affected by rTMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
  • Breast-feeding
  • History of head trauma with loss of consciousness for greater than 5 minutes
  • History of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder
  • Vagus Nerve Stimulator implanted
  • History of substance abuse or dependence in past 3 months
  • Failure to respond to an adequate course of ECT in the current depressive episode
  • History of ECT in the past 6 months

Treatment and study plan

Magstim Theta

Device

Thymatron System IV

Device

Primary outcomes

  1. Hamilton Rating Scale for Depression (HRSD), 24 item

    Time frame: A blinded rater will administer the test at Baseline, every Tuesday and Thursday during the treatment course and at the end of the MST course

Secondary outcomes

  1. Beck Depression Inventory

    Time frame: A blinded rater will administer the test at Baseline, every Tuesday and Thursady during the treatment course and at the end of the MST course

  2. Neuropsychological testings to assess the acute, short term, long term memory effects of the treatments

    Time frame: A blinded rater will administer various neurospychologiocal tests at various timepoints (baseline, within 3 days following the MST course and at 2 months following the MST course. Treatment Effect Battery (TEB) will be administered at each MST session.

Sponsors and collaborators

Lead sponsor

Sarah Lisanby

Other

Collaborators

  • Stanley Medical Research Institute
  • University of Texas

Registry information

Acronym: MST-2

Important dates

Study start
2002
Primary completion
2006
Study completion
2009
First posted
Sep 9, 2009
Registry last updated
Jun 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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